MedDataX Logo

Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak

NCT ID: NCT07295236

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2035-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to assess the impact of endoscopic vacuum therapy in patients who underwent total gastrectomy due to gastric cancer and developed esophago-jejunal anastomotic leakage. The main outcomes to be investigated are the following:

Primary endpoint: mortality rate Secondary endpoints: morbidity rate, time from AL diagnosis to discharge, patients satisfactory rate.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients who are diagnosed with asophago-jejunal anastomotic leakage will undergo endoscopic vacuum therapy. Local source control may be additionally achieved with para-anastomotic drains.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophagojejunal Anastomotic Leak

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

gastric cancer esophagojejunal anastomotic leak total gastrectomy Endoscopic vacuum therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endo-vac cohort

Patients who are diagnosed with asophago-jejunal anastomotic leakage will undergo endoscopic vacuum therapy. Local source control may be additionally achieved with para-anastomotic drains.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who developed esophago-jejunal anastomotic leak less than 50% of circumference of anastomosis
* patients who developed esophago-jejunal anastomotic leak and remained stable at the moment of diagnosis with no indications for diversion surgery

Exclusion Criteria

* unstable patients who developed esophago-jejunal anastomotic leak
* patients who developed esophago-jejunal anastomotic leak more than 50% or anastomotic circumference
* patients who rejected endoscopic vacuum therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ukrainian Society of Clinical Oncology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oleksii Dobrzhanskiy

Surgical oncoligist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oleksii Dobrzhanskyi, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute

Kyiv, , Ukraine

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Ukraine

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oleksii Dobrzhanskyi, MD

Role: CONTACT

Phone: +380638760185

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oleksii Dobrzhanskyi

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9947/2025

Identifier Type: -

Identifier Source: org_study_id